GUDIDData
eudamed_udi Primary ID: 08100322943909

ProciseDx Analyzer (UDI 08100322943909)

Manufactured by ProciseDx Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ProciseDx Analyzer - Primary ID 08100322943909

Device Regulatory Overview

The ProciseDx Analyzer (Model/Catalog Number: 4390) is a medical device manufactured by ProciseDx Inc.. This product is indexed under FDA Product Code / Category Classification W0201069099 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
4390
Product Code / EMDN
W0201069099
Device Name
ProciseDx Analyzer
Database Sync Date
2026-08-09 16:49:23

Full Regulatory Attributes

πŸ”’ Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of ProciseDx Analyzer?

The registered manufacturer of record for ProciseDx Analyzer is ProciseDx Inc..

What is the Primary UDI-DI identifier for ProciseDx Analyzer?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08100322943909.

What classification code is assigned to this device?

This device is registered under product classification code W0201069099.

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